The FAMHP participated in the improvement exercise ‘Benchmarking of European Medicines Agencies’ (BEMA) in 2023. This improvement exercise gives the agency an opportunity to evaluate performance and then further optimise it. The FAMHP successfully completed the exercise and achieved positive results; also, the average score per area increased compared to the previous edition in 2016.
The BEMA exercise is organised on a regular basis by the Network of Heads of Medicines Agencies (HMA). All authorities competent within Europe for medicines, both human and veterinary, can participate.
“The FAMHP participated in a BEMA exercise for the fourth time in 2023,” explains Annelies Cools of the Quality Division and Organisational Management. “BEMA offers our agency the opportunity to evaluate our performance, identify any bottlenecks in the organisation, learn more about good practices, and determine improvement actions.”
In practice, the BEMA exercise consists of two parts. First, a self-assessment that was conducted through questionnaires. Forty areas were identified for the survey: from strategic planning and leadership, to clinical trials, pharmacovigilance and inspections. For each area, a coordinator within the FAMHP was designated who, along with a support team, gathered the necessary input. The self-assessment was followed by a visit to our agency by three BEMA assessors from medicines authorities from other European countries. During this visit, the assessors used the self-assessment to conduct several interviews of the coordinators and their teams.
Quite a job
A great many services within the FAMHP participated in the BEMA exercise in one way or another. So proper coordination of the project was very important. Behind the scenes, the entire project was managed by the Quality Division and Organisational Management. “We provided both the overall organisation and coordination of the BEMA exercise, as well as support for the coordinators and their teams,” says Kathy Cromphout. Because there was also a lot of preparatory work involved. “For example, to make the whole project run smoothly, we created a SharePoint website where all the information about the BEMA exercise was collected,” adds Kathy Cromphout. “In addition, a roadmap was developed with the various steps and corresponding deadlines for this benchmarking exercise.”

Christelle Beeckmans – Kathy Cromphout – Annelies Cools – Fleur Peten
Positive results
And that good preparation was rewarded. The FAMHP has since successfully completed the BEMA exercise: the self-assessment was submitted on time and the interviews were very constructive. In late 2023, the FAMHP received the final BEMA report. The assessors noted a strong improvement in the FAMHP’s performance. The average score per area evolved from 3.55/5 (in 2016) to 4.1/5 (in 2023). “According to the BEMA assessors, the FAMHP does an excellent job in medicines availability. Indeed, the agency is taking a leading role in addressing the unavailability of medicines at both national and European levels,” explains Annelies Cools. Training and development also emerged as one of its strengths. Current knowledge and the need for expertise are regularly surveyed. “The FAMHP also scores strongly on internal audit, for which the Quality Division and Organisational Managementworks closely with auditors from other healthcare institutions and with the Federal Internal Audit Service,” adds Fleur Peten.
Continuous improvement
Of course, the BEMA exercise is interesting not only to know our strengths, but also and especially to identify bottlenecks and determine improvement actions. There is still room within the FAMHP for enhanced leadership support for quality management, more specifically for the implementation of improvement measures. More efforts can also be made to increase he FAMHP’s staff’s awareness of information security. This can be achieved through targeted training and exercises.
Based on the report from the BEMA assessors, an action plan was drawn up with some measures for improving the agency’s operations. Improvement measures were formulated for fifteen different areas. Management will closely monitor the implementation of these actions.
“The BEMA cycle spans a period of several years. After the completion of the BEMA V cycle in the second half of 2025, we will have a clear picture of the position of the Belgian agency compared to the authorities of the other European countries. The FAMHP and all its staff can already be proud of the positive results achieved and the increase in the average score,” concludes Christelle Beeckmans, Head of the Quality Division and Organisational Management.
Christelle Beeckmans
“The BEMA cycle spans a period of several years. After the completion of the BEMA V cycle in the second half of 2025, we will have a clear picture of the position of the Belgian agency compared to the authorities of the other European countries. The FAMHP and all its staff can already be proud of the positive results achieved and the increase in the average score,” concludes Christelle Beeckmans, Head of the Quality Division and Organisational Management.
Our FAMHP experts
Annelies Cools, Kathy Cromphout and Fleur Peten work in the Quality Division and Organisational Management under the direction of Christelle Beeckmans. Along with their colleagues, they support the FAMHP’s various services to manage their activities properly, and carry them out efficiently and effectively. They do this by coordinating audits, handling external complaints, monitoring improvement actions, managing risks and managing declarations of interest, among other things. Together, they also coordinate improvement exercises to continuously improve the agency’s operations.